At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gileads products.

You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs including financial responsibility. You will be responsible for the resource management of studies including ongoing assessment of resource needs and optimal deployment of resources to support a fluid One Ops workforce.

You will participate and engage in Clinical Operations and/or cross-functional organizational change initiatives. You may act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices external benchmarking and standardization across Clinical Operations.

In this role you will either act as an individual contributor or will be assigned people leader responsibilities People Leader Path according to skill set and business need. The proportion of your time allocated to study activities will be adjusted accordingly.

People Leader Path: You will manage a team of direct reports.

EXAMPLE RESPONSIBILITIES:

• Provides ongoing financial oversight of clinical trials/programs assigned.

• May provide input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate including supporting alignment and communications to other team members upon implementation.

• Provides guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.

• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.

• Partners with cross-functional teams to manage adjust and revise project timelines and budgets as needed.

• Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.

• Participates in the development of all study-related documentation including study protocols.

• Participates in the selection management and oversight of contract research organizations (CROs) / vendors including development of requests for proposals (RFPs).

• Anticipates obstacles and difficulties and implements solutions to achieve project goals including risk assessment and mitigation strategies.

• Resolves issues as needed within national and international regulations and guidelines.

• Uses all available tools to track oversee and communicate on program status to all key stakeholders.

• Participates in and/or leads departmental or interdepartmental strategic initiatives.

• As assigned initiates authors or otherwise contributes to standard operating procedure (SOP) development implementation and training.

• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.

• Ensures teams work complies with established practices policies and processes and any regulatory or other requirements.

• People Leader Path: Hires develops and retains diverse top talent on the team. Sets clear expectations for direct reports and coaches direct reports on their performance development and career interests.

REQUIREMENTS:

We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• BA / BS / RN with 8 or more years relevant clinical or related experience in life sciences or MA / MS / PharmD / PhD with 6 or more years relevant clinical or relatedexperience in life sciences.

• Minimum of 4 years cross-functional study management or related leadership experience in life sciences including multiple years experience managingstudy or project teams.

• Experience developing RFPs and selection and oversight/management of CROs or other vendors.

• Proven ability to successfully start-up manage and close-out clinical studies including authoring clinical study and regulatory documentation and SOPs.

• Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable proficiency.

Knowledge & Other Requirements

• Advanced knowledge of one or more disease or therapeutic areas as evidenced by independence in designing implementing and managing study team plans deliverables and resource management.

• Complete knowledge of full cycle study management from start-up to close-out.

• Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA) and other applicable national regulations International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.

• Proven ability to effectively author clinical study and regulatory documentation.

• Ability to lead and influence programs projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented highly-matrixed environment.

• Demonstrated effectiveness coaching guiding and directing the work of others effectively managing performance of others and developing team capabilities.

• Demonstrated effectiveness in proactively managing change.

• Strong communication and organizational skills.

• As required the ability to travel

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.